RE:RE:RE:RE:RE:RE:ONCY's Bracelet-1 was in HR+/HER2 negative breast cancerand Matt and Prof Heineken already told us that Bracelet-1 was not powered for statisical significance.
How many patients were in each arm? lets just remind the boys and girls shall we..
Bracelet-1
Cohort-1 (n=15) Pax
Cohort 2 (n=15) Pax + Pela
Primary endpoint for this trial was ORR, which was almost 3 times better than Pax alone.and exploratory endpoint PFS was better in Pela + Pax vs Pax by 3 months.but there was no difference in PFS from the IND213 trial, so ONCY has a mixed bag of results again. This might explain why the pps is in the wc. They need the PFS to statistically show improved OS, so they can use it as a surrogate end point... they have the OS data now... so they know the answer,. Question is WHY are they stalling?
why even bother talking about a Ph II---Ph III, if the "imminently" releasable Bracelet OS data will be used to obtain Accel. Approval... If you gain AA,m you can SELL product, whilst running a Ph IV trial... so WHY discuss Ph III...
Although, Matt did state in a call back in 2023 that the Phase III would be standard two arm trial... funny how he didn't mention AA. But he's just the CEO, can't trust what they tell us eh Noteable..?